There are many therapeutic indications today that pose problems in terms of technique, cost efficiency, or efficacy, or combinations thereof.
For example, following an interventional procedure, such as angioplasty or stent placement, a 5 Fr to 9 Fr arteriotomy remains. Typically, the bleeding from the arteriotomy is controlled through pressure applied by hand, by sandbag, or by C-clamp for at least 30 minutes. While pressure will ultimately achieve hemostasis, the excessive use and cost of health care personnel is incongruent with managed care goals.
Various alternative methods for sealing a vascular puncture site have been tried. For example, devices that surgically suture the puncture site percutaneously have been used. Suture is used because it is perceived as providing a reliable and tight closure of any wound where the suture can be properly placed, tied, and tightened. Suturing is relatively straightforward in most open surgical procedures. However, placement and tying of sutures in closed, minimally invasive procedures, e.g., in laparoscopic or catheter-based procedures, often require placement, tying, and tightening of a suture knot transcutaneously through a tissue tract. A variety of devices have been developed for the transcutaneous placement, tying, and tightening of suture knots through a tissue tract.
For example, when used for closure of vascular punctures, these devices deploy within a tissue tract to place a suture loop through tissue on opposite sides of the vascular puncture. Two free ends of the suture loop are brought out through the tissue tract. The loops are externally tied by the attending physician, forming a sliding knot in the suture loop. A tool, called a “knot pusher,” is deployed through the tissue tract for cinching the slidable knot over the loop. When used to suture vessel punctures, the knot pusher advances the knot through the tissue tract to locate the knot over the adventitial wall of the blood vessel, resulting in puncture edge apposition.
Despite the skill and due care involved in placing, tying, and tightening a suture knot using these devices, seepage of blood and fluids at the suture site and into the tissue tract can still occur. Under these circumstances, a “dry” femoral closure cannot be achieved. Hematoma formation can result, which can prolong a patient's return to ambulatory status without pain and immobilization.
Thus, there remains a need for fast and straightforward systems and methods to achieve suture closure through a tissue tract, which are substantially free of blood or fluid leakage about the suture site and into the tissue tract.